NORTH CHICAGO, Ill. and
CAMBRIDGE, Mass., Feb. 20, 2018 /PRNewswire/ -- AbbVie (NYSE:
ABBV), a global biopharmaceutical company, and Voyager
Therapeutics, Inc. (NASDAQ: VYGR), a clinical-stage gene therapy
company, today announced that they have entered into an exclusive
strategic collaboration and option agreement to develop and
commercialize vectorized antibodies directed against tau for the
treatment of Alzheimer's disease and other neurodegenerative
diseases. This collaboration combines AbbVie's monoclonal antibody
expertise, global clinical development and commercial capabilities
with Voyager's gene therapy platform and expertise that enables
generating adeno-associated viral (AAV) vectors for the treatment
of neurodegenerative diseases.
In healthy individuals, tau is an abundant protein in the brain
that promotes cellular stability and function. In the diseased
brain, altered tau accumulates, resulting in impaired brain
function and neuronal cell loss. The progressive spread of
abnormal tau in the brain closely correlates with progressive
neurodegeneration and symptom severity. However, one of the
current limitations with the use of weekly or biweekly infusions of
biologic therapies for neurodegenerative diseases is that only a
small amount of drug is able to make its way into the brain. This
collaboration seeks to develop a potential one-time treatment using
Voyager's gene therapy platform to reduce tau pathology through the
delivery of an AAV vector antibody that encodes the genetic
instructions to produce anti-tau antibodies within the brain.
"AbbVie is focused on developing treatments to meet the crushing
public health crisis presented by Alzheimer's and other
neurodegenerative diseases," said Jim
Sullivan, Ph.D., vice president, pharmaceutical discovery,
AbbVie. "Voyager's vectorized antibody platform presents an
innovative approach to addressing challenges in treating
neurological disorders associated with the administration of
biologic therapies. This collaboration has the potential to address
the needs of patients who live with conditions such as Alzheimer's
disease, progressive supranuclear palsy and frontotemporal
dementia."
"Combining AbbVie's leadership and deep expertise in monoclonal
antibody discovery, development and commercialization and our
ability to vectorize monoclonal antibodies is a natural fit, and we
are very pleased to collaborate with AbbVie to advance this
strategy towards the clinic in an effort to bring innovative
treatments to patients," said Steven
Paul, M.D., president and chief executive officer of
Voyager. "This collaboration also represents an important advance
in our strategy to leverage our AAV gene therapy platform and
programs through partnerships with biopharmaceutical companies that
bring complementary expertise and capabilities, in addition to
capital."
Details of the collaboration and financial terms
Under the terms of the collaboration and option agreement,
Voyager will perform research and preclinical development of
vectorized antibodies directed against tau, after which AbbVie may
select one or more vectorized antibodies to proceed into
IND-enabling studies and clinical development. Voyager will
be responsible for the research, IND-enabling and Phase 1 studies
activities and costs. Following completion of Phase 1 clinical
development, AbbVie has an option to license the vectorized tau
antibody program and would then lead further clinical development
and global commercialization for tauopathies, including Alzheimer's
disease and other neurodegenerative diseases. Voyager has an option
to share in the costs of clinical development for higher royalty
rates.
Voyager will receive an upfront cash payment of $69 million as well as up to $155 million in potential preclinical and Phase 1
option payments. In addition, Voyager is eligible to receive up to
$895 million in development and
regulatory milestones for each vectorized tau antibody compound and
is eligible to receive tiered royalties on the global commercial
net sales of the vectorized antibodies for tauopathies, including
Alzheimer's disease and other neurodegenerative diseases.
About AbbVie
AbbVie is a global, research-driven biopharmaceutical company
committed to developing innovative advanced therapies for some of
the world's most complex and critical conditions. The company's
mission is to use its expertise, dedicated people and unique
approach to innovation to markedly improve treatments across four
primary therapeutic areas: immunology, oncology, virology and
neuroscience. In more than 75 countries, AbbVie employees are
working every day to advance health solutions for people around the
world. For more information about AbbVie, please visit us at
www.abbvie.com. Follow @abbvie on Twitter, Facebook or
LinkedIn.
About Voyager Therapeutics
Voyager Therapeutics is a clinical-stage gene therapy company
focused on developing life-changing treatments for severe
neurological diseases. Voyager is committed to advancing the field
of AAV gene therapy through innovation and investment in vector
engineering and optimization, manufacturing and dosing and delivery
techniques. The company's pipeline focuses on severe neurological
diseases in need of effective new therapies, including advanced
Parkinson's disease, a monogenic form of ALS, Huntington's disease, Friedreich's ataxia,
frontotemporal dementia, Alzheimer's disease and severe, chronic
pain. Voyager has broad strategic collaborations with Sanofi
Genzyme, the specialty care global business unit of Sanofi, with
AbbVie, and the University of
Massachusetts Medical School. Founded by scientific
and clinical leaders in the fields of AAV gene therapy, expressed
RNA interference and neuroscience, Voyager Therapeutics is
headquartered in Cambridge,
Massachusetts. For more information, please visit
www.voyagertherapeutics.com.
Forward-Looking Statements: AbbVie
Some statements in this news release are, or may be considered,
forward-looking statements for purposes of the Private Securities
Litigation Reform Act of 1995. The words "believe," "expect,"
"anticipate," "project" and similar expressions, among others,
generally identify forward-looking statements. AbbVie cautions that
these forward-looking statements are subject to risks and
uncertainties that may cause actual results to differ materially
from those indicated in the forward-looking statements. Such risks
and uncertainties include, but are not limited to, challenges to
intellectual property, competition from other products,
difficulties inherent in the research and development process,
adverse litigation or government action, and changes to laws and
regulations applicable to our industry. Additional information
about the economic, competitive, governmental, technological and
other factors that may affect AbbVie's operations is set forth in
Item 1A, "Risk Factors," of AbbVie's 2017 Annual Report on Form
10-K, which has been filed with the Securities and Exchange
Commission. AbbVie undertakes no obligation to release publicly any
revisions to forward-looking statements as a result of subsequent
events or developments, except as required by law.
Forward-Looking Statements: Voyager
This press release contains forward-looking statements for the
purposes of the safe harbor provisions under The Private Securities
Litigation Reform Act of 1995 and other federal securities laws.
The use of words such as "may," "might," "will," "would," "should,"
"expect," "plan," "anticipate," "believe," "estimate,"
"undoubtedly," "project," "intend," "future," "potential," or
"continue," and other similar expressions are intended to identify
forward-looking statements. For example, all statements Voyager
makes regarding the potential benefits and future operation of the
option and collaboration agreement with AbbVie, including any
potential future payments thereunder, the initiation, timing,
progress and reporting of results of its preclinical programs and
clinical trials and its research and development programs, its
ability to advance its AAV-based gene therapies into, and
successfully initiate, enroll and complete, clinical trials, the
potential clinical utility of its product candidates, its ability
to continue to develop its product engine, its ability to develop
manufacturing capability for its products, its ability to add new
programs to its pipeline, its ability to enter into new
partnerships or collaborations, its expected cash, cash equivalents
and marketable debt securities at the end of a fiscal period and
anticipation for how long expected cash, cash equivalents and
marketable debt securities will last, and the timing or likelihood
of its regulatory filings and approvals, are forward looking. All
forward-looking statements are based on estimates and assumptions
by Voyager's management that, although Voyager believes to be
reasonable, are inherently uncertain. All forward-looking
statements are subject to risks and uncertainties that may cause
actual results to differ materially from those that Voyager
expected. Such risks and uncertainties include, among others,
those related to the initiation and conduct of preclinical studies
and clinical trials, the availability of data from clinical trials
and the expectations for regulatory submissions and approvals; the
continued development of the product engine; Voyager's scientific
approach and general development progress; the availability or
commercial potential of Voyager's product candidates; the
sufficiency of cash resources; and need for additional financing.
These statements are also subject to a number of material risks and
uncertainties that are described in Voyager's most recent Annual
Report on Form 10-K filed with the Securities and Exchange
Commission, as updated by its subsequent filings with the
Securities and Exchange Commission. Any forward-looking statement
speaks only as of the date on which it was made. Voyager
undertakes no obligation to publicly update or revise any
forward-looking statement, whether as a result of new information,
future events or otherwise, except as required by law.
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SOURCE AbbVie